FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
147841–147864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1985
TENS-AID STERILE ELECTRODES FOR POST-OP TENS
K852298 · GXY
Staodynamics, Inc.
Neurology · 26d
Cleared Jun 24, 1985
ST-460 SPIRO ANALYZER SPIROMETER
K852308 · BZG
Futuremed Div. of Future Impex Corp.
Anesthesiology · 26d
Cleared Jun 24, 1985
ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR
K852515 · BZQ
Alternative Design Systems, Inc.
Anesthesiology · 11d
Cleared Jun 21, 1985
FUKUDA DENSHI EH-11
K834059 · DXG
Fukuda Denshi USA, Inc.
Cardiovascular · 574d
Cleared Jun 21, 1985
ELISA FOR HERPES SIMPLEX VIRUS
K843077 · LGC
Scientific Research
Microbiology · 319d
Cleared Jun 21, 1985
TROCHANTER CABLE GRIP SYSTEM
K844068 · KTT
Howmedica Corp.
Orthopedic · 246d
Cleared Jun 21, 1985
CARDIOVASCULAR CUSTOM SURGICAL KIT
K844593 · DYB
Xanmed Corp.
Cardiovascular · 207d
Cleared Jun 21, 1985
PERCUTANEOUS ANGIOGRAPHIC NEEDLES
K845037 · DYB
Mallinckrodt Critical Care
Cardiovascular · 176d
Cleared Jun 21, 1985
ENDO-TUBE
K850664 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 121d
Cleared Jun 21, 1985
GRAVITY TRACTION TABLE
K851007 · INQ
William F. Trinkaus
Physical Medicine · 101d
Cleared Jun 21, 1985
SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT
K851033 · LJP
Syncor Intl. Corp.
Microbiology · 101d
Cleared Jun 21, 1985
PENOX LIFT CHAIR
K851218 · INO
Penox Technologies, Inc.
Physical Medicine · 87d
Cleared Jun 21, 1985
GIBCO MYCOTECT 189-5670
K851275 · KIW
Gibco Laboratories Life Technologies,...
Microbiology · 81d
Cleared Jun 21, 1985
VIRTRAN VIRAL TRANPORTER
K851378 · LIO
Diagnon Corp.
Microbiology · 74d
Cleared Jun 21, 1985
VENTREZYME ALLERGEN DATA REDUCTION SYSTEM
K851403 · JQW
Ventrex Laboratories, Inc.
Immunology · 73d
Cleared Jun 21, 1985
MULTICOR S, MODELS 330A/331A
K851420 · DXY
Cordis Corp.
Cardiovascular · 73d
Cleared Jun 21, 1985
TIMENTIN 85 MCG. SENSI-DISC
K851622 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 64d
Cleared Jun 21, 1985
MANAN MENGHINI NEEDLE
K851836 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 54d
Cleared Jun 21, 1985
MANAN CHIBA PTC NEEDLE
K851838 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 56d
Cleared Jun 21, 1985
MANAN MADAYAG PTC NEEDLE
K851839 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 56d
Cleared Jun 21, 1985
LASER PREALBUMIN TEST
K851912 · JZJ
Behring Diagnostics, Inc.
Immunology · 51d
Cleared Jun 21, 1985
SS-A(RO) & SS-B(LA) ANTIBODY ASSAY
K852033 · DHN
Meloy Laboratories, Inc.
Immunology · 43d
Cleared Jun 21, 1985
PRIVATAN HOME TANNING CENTER
K852290 · FTC
Privatan, Inc.
General & Plastic Surgery · 23d
Cleared Jun 20, 1985
TEMREX-DENTIN VARNISH
K851030 · LBH
Temrex Corp.
Dental · 100d